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The aim of our study is to determine the efficacy of oral diclofenac potassium with or without vaginal dinoprostone prior to hysterosalpingography in primarily infertile patients on the pain scores during HSG.
hysterosalpingography is a diagnosis procedure in the evaluation of infertile women and considered to be the traditional and the gold standard in the assessment of the patency of the fallopian tubes. The major disadvantage of hysterosalpingography is pain. In a study reported the patients complained of moderate to severe pain during the procedure. It is reported that some patients undergoing hysterosalpingography was more stressful and anxiety and effect on pain scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal dinoprostone (6 mg) 6 hours prior to the procedure |
|
| Group B | Placebo Comparator | patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal placebo 6 hours prior to the procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diclofenac potassium + dinoprostone | Drug | patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal dinoprostone (6 mg) 6 hours prior to the procedure by the patient |
| Measure | Description | Time Frame |
|---|---|---|
| Mean pain score during hysterosalpigography by visual analog scale | pain during hysterosalpigography assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of pain | Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10 | 30 minutes after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
primary infertility female
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| Name | Affiliation | Role |
|---|---|---|
| nahla w Shady, md | Aswan universirty | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aswan University Hospital | Aswān | 81528 | Egypt |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| D015232 | Dinoprostone |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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double blind placebo controlled trial
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double blind placebo controlled trial
| diclofenac potassium + placebo | Drug | patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal placebo 6 hours prior to the procedure by the patient |
|
| D000091662 | Genital Diseases |
| D007246 | Infertility |
| D011458 |
| Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |